Esomeprazole - Medication and Pregnancy KB

Esomeprazole

Exposed non-exposed, cohort studies

Study	Country Study period Study design	Data source	Exposure definition	Non-exposure definition	Exposition period	Sample size (exposed/unexposed) Or (case / control)	Remarks	Risk of bias
Broe (Controls unexposed, general pop) 2025	Denmark 2004 - 2017 population based cohort retrospective	Danish national health registries (the Danish Medical Birth registry, the Danish Civil Registration Registry, the Danish National Prescription Registry, the Danish National Patient registry and the Cause of Death Register).	Singleton livebirths whose mothers had filled a prescription for Esomeprazole between the first day in the last menstrual period (LMP) and the end of the first trimester (91days after LMP).	unexposed (general population or NOS) Singleton livebirths of women who did not redeem any drug prescription between 90 days prior to LMP and the end of the first trimester.	1st trimester	1104 / 481595	Infants with chromosomal abnormalities (ICD-10 codes Q90– Q99) were excluded from all analyses.
Broe (Controls unexposed, general pop) 2025	Denmark 2004 - 2017 population based cohort retrospective		Exposure was determined using the Prescription register that contains individual-level prescription data from all Danish outpatient pharmacies.		1st trimester	1104 / 481595
Broe (Controls unexposed, sick) 2025	Denmark 2004 - 2017 population based cohort retrospective	Danish national health registries (the Danish Medical Birth registry, the Danish Civil Registration Registry, the Danish National Prescription Registry, the Danish National Patient registry and the Cause of Death Register).	Singleton livebirths whose mothers had filled a prescription for Esomeprazole between the first day in the last menstrual period (LMP) and the end of the first trimester (91days after LMP).	unexposed, sick Singleton livebirths born to women who were treated with the individual drug of interest during the last year before pregnancy, but not during pregnancy.	1st trimester	1104 / 2773	Infants with chromosomal abnormalities (ICD-10 codes Q90– Q99) were excluded from all analyses.
Broe (Controls unexposed, sick) 2025	Denmark 2004 - 2017 population based cohort retrospective		Exposure was determined using the Prescription register that contains individual-level prescription data from all Danish outpatient pharmacies.		1st trimester	1104 / 2773
Choi a 2023	South Korea 2011 - 2020 retrospective cohort (claims database)	The National Health Insurance Service–National Health Information Database of South Korea, longitudinal health care records of more than 50 million inhabitants (approximately 99% of the South Korean population).	Pregnant women with one or more prescriptions for Esomeprazole during the first trimester (defined as the start of pregnancy to the 90th day of gestation).	unexposed, sick Pregnant women with no filled Proton Pump Inhibitor prescriptions from 90 days before pregnancy through the end of the first trimester (with a propensity-score, made by stratification notably concerning the indications => unexposed sick).	1st trimester	12516 / 2655676	In South Korea, 7 PPIs (omeprazole, esomeprazole, lansoprazole, dexlansoprazole, pantoprazole, rabeprazole, and ilaprazole) are available only with a prescription, and no over-the-counter PPIs are available.
Choi a 2023			Prescription database.		1st trimester	12516 / 2655676
Choi b 2023	South Korea 2008 - 2019 retrospective cohort (claims database)	The National Health Insurance Service–National Health Information Database of South Korea, longitudinal health care records of more than 50 million inhabitants (approximately 99% of the South Korean population).	Pregnant women that filled a prescription for Esomeprazole between the start of pregnancy and the 245th day of gestation.	unexposed, sick Pregnant women without exposure to proton pump inhibitors (PPIs) from 90 days before pregnancy to the delivery date.	during pregnancy (anytime or not specified)	12868 / 2121323	Unexposed group adjusted with propensity-score, made by stratification, notably concerning the indications => considered as unexposed sick (mathematical deformation of total population). In South Korea, PPIs only available with a prescription.
Choi b 2023			Prescription database.		during pregnancy (anytime or not specified)	12868 / 2121323
Pasternak 2010	Denmark 1996 - 2008 population based cohort retrospective	the Medical Birth Register, the Prescription Drug Register, the National Patient Register, The Central Person Register and Statistics Denmark	Infants born to women who were exposed to esomeprazole (any filling of esomeprazole prescription at any time during the period from 4 weeks before conception through the end of the first trimester) (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed (general population or NOS) Infants born to women not exposed to PPIs (all the women who were not exposed at any time during their pregnancy).	1st trimester, 2nd and/or 3rd trimester, preconception-only	668 / 832031
Pasternak 2010	Denmark 1996 - 2008 population based cohort retrospective		The Prescription Drug Register provided information on all esomeprazole prescriptions filled by women in the cohort between 4 weeks before conception and delivery.		1st trimester, 2nd and/or 3rd trimester, preconception-only	668 / 832031

Case-control studies

Study	Country Study period Study design	Data source	Case	Control	Exposition	Exposition period	Sample size (exposed/unexposed) Or (case / control)	Remarks	Risk of bias

Risk of bias: : NA; : low; : moderate; : serious; : critical; : unclear;

Empty. There are no case-control studies available for this drug.

master protocol